- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02813304
Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy
February 25, 2019 updated by: Jean-Sébastien Roy, Laval University
Rest or Gradual Reloading in Acute Presentations of Rotator Cuff Tendinopathy - A Randomised Control Trial
The primary objective of this study is to compare the short-term effectiveness (2 and 6 weeks following the start of the rehabilitation program), in terms of symptoms and functional limitations, of a rehabilitation program centered on gradual reloading to a rehabilitation program centered on rest and cryotherapy in individuals with acute rotator cuff tendinopathy.
The secondary objective is to explore the effects of these programs on shoulder control (acromiohumeral distance), subacromial structures (supraspinatus tendon thickness) and central pain modulation.
The hypothesis is that the rehabilitation program centered on gradual reloading will lead to a faster improvement at week 2 and 6 when compared to the program centered on rest and cryotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
44 adults (aged between 18 and 65) with acute (< 6 weeks) unilateral symptomatic RC tendinopathy will be recruited.This single-blind (assessor), parallel-group RCT will include three evaluation sessions over 6 weeks (baseline, week 2, week 6) and one meeting with the treating physiotherapist (right after the baseline evaluation).
All participants will take part in the baseline evaluation.
They will first complete a questionnaire on sociodemographic, symptomatology and comorbidity, as well as self-administered questionnaires that evaluate symptoms and functional limitations (DASH, WORC and BPI).
Then, ultrasonographic (US) measurements of AHD and of the supraspinatus tendon and subacromial bursal thickness will be conducted.
Thereafter, pain inhibitory control will be assessed using conditioned pain modulation.
Finally, the corticospinal excitability of the infraspinatus muscle will be evaluated.
Thereafter, participants will be randomly assigned to one of two intervention groups, and then take part in their assigned home program.
At week 2 and 6, the self-administered questionnaires will be re-administered (by phone for the week 6 evaluation).
A global rating of change question (with % of change since baseline) will also be completed at week 2 and 6.
US measurements, conditioned pain modulation and corticospinal excitability will only be revaluated at week 2. To evaluate the effectiveness of blinding, the assessor will complete a question related to his/her opinion of the allocation at week 2. The study will be carried out at the Centre interdisciplinaire de recherche en réadaptation et en intégration sociale (CIRRIS) by two different physiotherapists and in two different laboratories.
Ethics approval will be obtained from Institutional Review Board of IRDPQ.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Quebec City, Quebec, Canada
- Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 18 and 65 years old
- Acute (< 6 weeks) unilateral symptomatic rotator cuff tendinopathy
- Positive sign in each of the following categories: a) painful arc of movement, b) positive Neer or Kennedy-Hawkins tests, and c) pain on resisted isometric lateral rotation or abduction, or positive Jobe test.
Exclusion Criteria:
- Fracture at the symptomatic upper limb;
- Previous neck or shoulder surgery;
- Shoulder pain reproduced during active neck movement;
- Shoulder capsulitis;
- Clinical signs of a full thickness rotator cuff tear;
- Rheumatoid, inflammatory, or neurological diseases;
- Behavioural or cognitive problems.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gradual reloading
Participants will be asked to perform isometric strengthening exercises in lateral rotation and abduction (see Table 1).
In a sitting position (with folded towel between body and arm), participants will place their affected arm by the side with the elbow gently tucked in close to the body, elbow flexed at 90°, and the thumb pointing upwards.
The opposite hand (the uninvolved side) will resist the lateral rotation and abduction.
They will be asked to push against the uninvolved hand, building up to sub-maximal pressure (approximately 50% to 75% of the maximum possible force; practice during the meeting with the treating physiotherapist using EMG recording) over five seconds.
|
Participants will be asked to perform isometric strengthening exercises in lateral rotation and abduction.
Participants will place their affected arm by the side with the elbow gently tucked in close to the body, elbow flexed at 90°, and the thumb pointing upwards.
The opposite hand will resist the lateral rotation and abduction.
They will be asked to push against the uninvolved hand, building up to sub-maximal pressure (approximately 50% to 75% of the maximum possible force) over five seconds.
Then the contraction will be slowly released.
A maximum pain level of 5/10 will be accepted when performing the contraction.
Elevation movements will also be performed 3 times a day in the frontal, sagittal and scapular plane.
|
Active Comparator: Rest and cryotherapy
Participants will be asked to apply ice wrap on their painful shoulder 3 times a day over the area of pain for 15 minutes.
They will be asked to place the ice wrap inside a damp towel cloth (minimise the risk of an ice burn) and secure around the shoulder with a towel.
After the 15 minutes, they will be asked to perform gentle, slow, pain free shoulder movements that do not provoke pain.
All participants will be provided with a commercial ice wrap and a towel cloth.
They will also be asked to avoid painful movements, working above shoulder level, repeated or sustained elevation movements and lifting weights.
|
Participants will be asked to apply ice wrap on their painful shoulder 3 times a day over the area of pain for 15 minutes.
They will be asked to place the ice wrap inside a damp towel cloth (minimise the risk of an ice burn) and secure around the shoulder with a towel.
After the 15 minutes, they will be asked to perform gentle, slow, pain free shoulder movements that do not provoke pain.
All participants will be provided with a commercial ice wrap.
They will also be asked to avoid painful movements, working above shoulder level, repeated or sustained elevation movements and lifting weights.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disabilities of the Arm, Shoulder and Hand questionnaire
Time Frame: Change from baseline at 2 weeks, change from baseline at 6 weeks
|
Generic questionnaire assessing any upper limb disorders
|
Change from baseline at 2 weeks, change from baseline at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Ontario Rotator Cuff index
Time Frame: Change from baseline at 2 weeks, change from baseline at 6 weeks
|
Questionnaire specific to rotator cuff disorders
|
Change from baseline at 2 weeks, change from baseline at 6 weeks
|
Short form of Brief Pain Inventory (questions 1-6 only)
Time Frame: Change from baseline at 2 weeks, change from baseline at 6 weeks
|
Pain questionnaire
|
Change from baseline at 2 weeks, change from baseline at 6 weeks
|
Acromiohumeral distance in cm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner
Time Frame: Change from baseline at 2 weeks
|
Change from baseline at 2 weeks
|
|
Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner
Time Frame: Change from baseline at 2 weeks
|
Change from baseline at 2 weeks
|
|
Percentage change in pain perception using Conditioned Pain Modulation equipment
Time Frame: Change from baseline at 2 weeks
|
This measurement represents the effectiveness of descending inhibitory mechanisms
|
Change from baseline at 2 weeks
|
Isometric shoulder external rotation strength
Time Frame: Change from baseline at 2 weeks
|
Measured using hand-held digital dynamometer
|
Change from baseline at 2 weeks
|
Isometric shoulder abduction strength
Time Frame: Change from baseline at 2 weeks
|
Measured using hand-held digital dynamometer
|
Change from baseline at 2 weeks
|
Shoulder flexion, external rotation at 0 degrees and 90 degrees abduction, internal rotation at 90 degrees abduction
Time Frame: Change from baseline at 2 weeks
|
Measured using a digital inclinometer
|
Change from baseline at 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
June 21, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (Estimate)
June 24, 2016
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 25, 2019
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016- 494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Rotator Cuff Tendinopathy
-
Shin Kong Wu Ho-Su Memorial HospitalCompletedRotator Cuff Tear | Ultrasonography | Rotator Cuff TendinopathyTaiwan
-
University of Alabama at BirminghamTerminatedPartial Tear of Rotator Cuff | Tendinopathy of Rotator CuffUnited States
-
InGeneron, Inc.Active, not recruitingRotator Cuff Tear | Rotator Cuff TendinitisUnited States
-
Sutherland Medical CenterActive, not recruitingRotator Cuff Tears | Rotator Cuff TendinosisPoland
-
National Taiwan University HospitalUnknownRotator Cuff Tears | Rotator Cuff TendinosisTaiwan
-
University of California, DavisCompletedRotator Cuff TendonitisUnited States
-
Michael KhazzamTerminatedRotator Cuff Tendinitis | Full Thickness Rotator Cuff TearUnited States
-
Guna S.p.aRecruitingRotator Cuff Injuries | Tendinopathy | Rotator Cuff Tendinitis | Syndrome Rotator Cuff | Tendinoses, Rotator CuffItaly
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRecruitingShoulder Rotator Cuff TendinitisFrance
-
Clinical Exercise Physiology and Rehabilitation...Not yet recruitingRotator Cuff Tear or Rupture, Not Specified as Traumatic | Rotator Cuff Tears | Rotator Cuff Tendinosis | Rotator Cuff Syndrome | Rotator Cuff Impingement
Clinical Trials on Gradual reloading
-
STAVROS G DRAKOSAmerican Heart AssociationRecruiting
-
Istanbul University - Cerrahpasa (IUC)CompletedObstructive Sleep Apnea SyndromeTurkey
-
University of California, San FranciscoQuitbit, Inc.Completed
-
Maimonides Medical CenterCompletedRespiratory Distress SyndromeUnited States
-
Cairo UniversityNot yet recruiting
-
King's College LondonCompletedAnorexia NervosaUnited Kingdom
-
University of North Carolina, Chapel HillAmerican Psychological Association (APA); Association for Behavioral and Cognitive...Completed
-
Aalborg UniversityCompletedOsgood Schlatter DiseaseDenmark
-
University of PennsylvaniaCompletedAtherosclerotic Cardiovascular DiseaseUnited States
-
Rigshospitalet, DenmarkRecruitingAneurysmal Subarachnoid Hemorrhage | HydrocephalusNorway, Denmark